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Study to Evaluate the Efficacy of Alefacept to Treat Palmar Plantar Pustulosis

This study has been completed.
Sponsor:
Collaborator:
Biogen Idec
Information provided by:
The Guenther Dermatology Research Centre
ClinicalTrials.gov Identifier:
NCT00301002
First received: March 8, 2006
Last updated: November 21, 2006
Last verified: November 2006
  Purpose

The purpose of this study is to determine if Alefacept is effective in the treatment of palmar plantar pustulosis.


Condition Intervention Phase
Psoriasis
Palmoplantaris Pustulosis
Pustular Psoriasis of Palms and Soles
Pustulosis Palmaris et Plantaris
Pustulosis of Palms and Soles
Drug: Alefacept
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Open-Label Study to Evaluate the Safety and Observe the Effectiveness of 16 Weeks of Alefacept in Palmar Plantar Pustulosis (IST 92)

Resource links provided by NLM:


Further study details as provided by The Guenther Dermatology Research Centre:

Primary Outcome Measures:
  • percentage change in PPPASI from baseline

Secondary Outcome Measures:
  • number of subjects with PPPASI 75
  • number of subjects with PPPASI 50
  • number of subjects with very mild/clear PGA
  • number of subjects with no pustules

Estimated Enrollment: 15
Study Start Date: June 2005
Estimated Study Completion Date: October 2006
Detailed Description:

Palmar plantar pustulosis is a chronic, disabling skin condition which is difficult to treat since it is often recalcitrant to current treatments and associated with high recurrence rates. This condition appears to be a T lymphocyte mediated condition and is thought by some to be a subtype of psoriasis. Alefacept affects T cell activation and induces apoptosis of memory T cells. It has been shown to be efficacious in the treatment of psoriasis vulgaris and may be associated with prolonged remissions. There is extremely limited experience with use of Alefacept in Palmar Plantar Pustulosis. This pilot trial should provide additional information concerning its use for this indication.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have stable, moderate, severe or very severe palmar plantar pustulosis.
  • Must have a minimum of at least 3 pustules on 1 sole or palm.
  • Must give written informed consent.
  • Subjects must be 18 years of age or older.
  • Adult Males and non-pregnant, non-lactating females.
  • Female subjects of childbearing potential must state that they are using measures to avoid conception through active means.
  • Subjects must be in general good health with no other skin disease, disease state or physical condition which would impair evaluation of palmar plantar pustulosis or which would increase their health risk by study participation.
  • Subjects must be willing to receive a 15 mg IM injection of Alefacept weekly for 16 weeks.

Exclusion Criteria:

  • Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.
  • Current enrollment in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy.
  • Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within the 3 months prior to the first dose of investigational drug.
  • Any subject whose CD4+ T-lymphocyte count at study entry is less than the lower limit of normal per reference laboratory.
  • Treatment with another investigational drug or approved therapy for investigational use within 28 days prior to investigational drug administration.
  • Treatment with psoralen + ultraviolet A (PUVA), systemic retinoids, systemic steroids, methotrexate, cyclosporine, azathioprine, thioguanine, etanercept, efalizumab, infliximab, adalimumab or mofetil or other systemic immunosuppressant agents within the 28 days prior to investigational drug administration.
  • Ultraviolet B (UVB) phototherapy within 14 days prior to investigational drug administration.
  • Treatment within 7 days with topical agents (e.g. tar, anthralin, calcipotriol, tazarotene, steroids) which might have an effect on palmar plantar pustulosis.
  • Known HIV, Hepatitis B or C seropositivity or tuberculosis infection.
  • Significant abnormal chemistry, i.e. liver function tests greater than 3 times the upper limit of normal.
  • Allergy to Alefacept or any of the components of the formulation.
  • Known malignancy or history of malignancy within the previous 5 years (with the exception of basal cell carcinoma of the skin or squamous cell carcinoma in situ of the skin that has been treated with no evidence of recurrence.)
  • Previous treatment with alefacept.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301002

Locations
Canada, Ontario
The Guenther Dermatology Research Centre
London, Ontario, Canada, N6A 3H7
Sponsors and Collaborators
The Guenther Dermatology Research Centre
Biogen Idec
Investigators
Principal Investigator: Lyn C Guenther, MD, FRCPC The Guenther Dermatology Research Centre
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00301002     History of Changes
Other Study ID Numbers: IST 92
Study First Received: March 8, 2006
Last Updated: November 21, 2006
Health Authority: Canada: Health Canada

Keywords provided by The Guenther Dermatology Research Centre:
safety
effectiveness
Alefacept
Palmar
Plantar
Pustulosis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Alefacept
Dermatologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014